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NCT Number: NCT06903377

Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer

This is a multicenter Phase I/II study for patients with advanced non-small cell lung cancer who have failed PD-1/L1 therapy, aiming to evaluate the safety of ZG005 in combination with Gecacitinib in this population, as well as the preliminary efficacy of this combination regimen.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Xinghao Ai

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fully understand this study and voluntarily sign the ICF.
  • Age 18-75 years, no gender restriction.
  • Patients with locally advanced or recurrent/metastatic squamous and/or non-squamous non-small cell lung cancer confirmed by histology/cytology, unsuitable for radical therapy.

Exclusion criteria

  • Medical history, CT scan, or MRI indicates the presence of CNS metastases.
  • Other malignancies within 5 years.
  • Any other reason deeming the participant unsuitable for the study, as judged by the investigator.

Treatment and study plan

ZG005 for Injection

Biological

intravenous infusion

Other names: ZG005

Gecacitinib Hydrochloride Tablets

Drug

Oral

Other names: Gecacitinib

Primary outcomes

  1. Adverse Event (AE)

    Time frame: Up to 2 years

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Cong Zhang

CONTACT

[email protected]

17602176888

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

A Multicenter, Open-label, Dose-Escalation and Dose-Expansion Phase I/II Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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